Cleared Traditional

Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

K152106 · VATECH Co., Ltd. · Radiology
Oct 2015
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K152106 is an FDA 510(k) clearance for the Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 23, 2015, 86 days after receiving the submission on July 29, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K152106 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2015
Decision Date October 23, 2015
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.